Evaluation of Axillary Reverse Mapping (ARM) in Clinically Axillary Node Negative Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- histopathologic examination of ARM +ve LN
研究概览
简要总结
study patients; axillary node negative breast cancer female, 74 patients randomly allocated in two groups each 37 patients , group I , where axillary reverse mapping(ARM) +ve nodes were preserved and axillary lymph node dissection completed.and group II where axillary reverse mapping +ve nodes were taken with axillary lymph node dissection(ALND) primary outcome is histopathological examination of a ARM +ve lymph nodes and volume measurements of the ipsilateral arm for development of lymphedema at 6 ,12 , and 24 months
详细描述
This study is comparative clinical trial carried out in the period between February 2015 and August 2019 on 74 female patients with early breast cancer. All patients were informed and signed a written consent. The study was approved from institutional review board (IRB) and ethical committee of our university.
Patient selection Patients included in the study are female patients above 18 years old, known breast cancer with clinically negative nodal metastasis who were admitted for completion ALND, after positive sentinel lymph node biopsy (SLNB).
Patients excluded from the study are those who had received chemotherapy for breast cancer, recurrent cases after conservative breast surgery, bilateral disease and pregnant cases.
Patients were randomly divided into two equal groups each 37 patients, group A; (ARM preserving ALND), where arm lymphatics and lymph nodes were identified and preserved, subsequently ALND was completed, group B; where arm lymphatics and lymph nodes were identified, marked and removed with ALND.
Technical procedures:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •clinically free breast cancer
- •sentinle LN positive
排除标准
- •patients on chemotherapy for breast cancer
- •recurrent cases after conservative breast surgery
- •bilateral disease and pregnant cases
结局指标
主要结局
histopathologic examination of ARM +ve LN
时间窗: IMMEDIATE POSTOPERATIVE
EITHER +VE OR -VE
ARM LYMPHOEDEMA
时间窗: 2 years postoperative
INCREASE OF THE ARM VOLUME BY 10%
次要结局
- restriction of shoulder movement(2 years)
研究者
Hazem Nour Abdellatif
Assistant professor
Zagazig University